Actively Recruiting
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
Led by Novartis Pharmaceuticals · Updated on 2026-05-06
220
Participants Needed
15
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.
CONDITIONS
Official Title
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the extension study.
- Completed the parent zigakibart study, whether received the drug or placebo.
- Investigator believes participant may benefit from open-label zigakibart 600 mg subcutaneous every two weeks.
You will not qualify if you...
- Withdrew early from prior zigakibart studies in IgAN for any reason.
- Receiving chronic dialysis (30 days or more) or needing a kidney transplant at first treatment in this study.
- Had acute kidney injury within 4 weeks before first treatment in this study.
- Suspected or diagnosed with rapidly progressive glomerulonephritis or other glomerulopathy at first treatment.
- Received live vaccination within 12 weeks before treatment or plans live vaccination within 6 months after last dose.
- Used systemic corticosteroids or other immunosuppressive treatments for more than 2 weeks in the 12 weeks before treatment; used rituximab within 180 days before treatment.
- Have a current severe infection or history of recurrent severe infections.
- Newly diagnosed with certain viral infections (hepatitis A, B, C, or HIV), except some treated hepatitis C cases.
- Newly diagnosed with cancer, except fully treated basal cell carcinoma, cervical carcinoma in situ, or low-risk prostate cancer.
- Pregnant, breastfeeding, or planning pregnancy/sperm donation during study and 24 weeks after last dose.
- Have other significant medical or psychiatric disorders that pose an unfavorable risk.
- Confirmed low IgG levels (<3 g/L) before first treatment.
- Women able to become pregnant not using highly effective contraception during and 24 weeks after treatment.
- Men not willing to use highly effective contraception during and 24 weeks after treatment or willing to donate sperm during this time.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Colorado Kidney Care Nephrology
Denver, Colorado, United States, 80230
Actively Recruiting
2
Nephrology Associates Of Central FL
Orlando, Florida, United States, 32806
Actively Recruiting
3
NY Nephrology
Clifton Park, New York, United States, 12065
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
5
Knoxville Kidney Center Pllc
Brentwood, Tennessee, United States, 37027-4528
Actively Recruiting
6
Dallas Renal Group
Dallas, Texas, United States, 75230
Actively Recruiting
7
Dallas Renal Group
Dallas, Texas, United States, 75230
Actively Recruiting
8
Novartis Investigative Site
La Plata, Buenos Aires, Argentina, B1902COS
Actively Recruiting
9
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., Argentina, 1280
Actively Recruiting
10
Novartis Investigative Site
Santa Fe, Argentina, S3000EPV
Actively Recruiting
11
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
12
Novartis Investigative Site
Cheonan, Chungcheongnam-do, South Korea, 330-721
Actively Recruiting
13
Novartis Investigative Site
Guri-si, Gyeonggi-do, South Korea, 471-701
Actively Recruiting
14
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
15
Novartis Investigative Site
Seoul, Seoul, South Korea, 03080
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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